EUCTR2021-006056-13-DE进行中（未招募）1 期
Open-Label, Uncontrolled, Single dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of AZD7442 in Pediatric Participants Aged = 29 weeks Gestational Age to < 18 years - TRUST
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participant must be aged = 29 weeks to < 18 years of age.
- •Participant must weigh a minimum of 1.5 kg.
- •Increased risk of severe COVID-19 because of immunocompromised state or one or more comorbid conditions that increase the risk of severe COVID-19.
- •Medically stable (disease not requiring significant change in therapy or hospitalization for worsening disease during the one month prior to enrollment).
- •A negative RT-PCR test collected = 3 days before Day 1 or a negative rapid SARS-CoV-2 antigen test at screening.
- •No COVID-19 symptoms prior to enrollment within 10 days of dosing.
- •Increased risk for SARS-CoV-2 infection.
- •Increased risk of severe COVID-19 because of immunocompromised state or one or more comorbid conditions that increase the risk of severe COVID-19.
- •Medically stable (disease not requiring significant change in therapy or hospitalization for worsening disease during the one month prior to enrollment).
- •A positive RT-PCR test collected = 3 days before Day 1 or a positive rapid SARS-CoV-2 antigen test at screening.
- •Symptomatic participants must be dosed with IMP no more than 7 days from the self-reported date of first reported sign/symptom.
- •= 92% oxygen saturation at rest within 24 hours before Day 1 unless the participant is a regular receiver of chronic supplementary oxygen for a lung condition.
- •Participants hospitalized with COVID-19 between the onset of symptoms and dosing AZD7442 of = 7 days.
- •A positive RT-PCR test collected = 3 days before Day 1 or a positive rapid SARS-CoV-2 antigen test at screening.
- •Spontaneous blood Alanine Aminotransferase (ALT)/Aspartate Transaminase (AST) levels = 5 times the ULN.
- •Glomerular Filtration Rate (GFR) = 30 mL/min.
- •ROUTE OF ADMINISTRATION
- •- Participants will receive IM AZD7442 unless they meet any of the following criteria for IV
- •administration:
- •Severe COVID-19.
- •Contraindication of intramuscular (IM) dose due to thrombocytopenia, coagulation defects or any other condition that would compromise the absorption of AZD7442 or safety of the participant.
- •A central intravenous (IV) line.
- •Physician considers IV the appropriate route.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •MEDICAL CONDITIONS
- •Cohort 1: Significant infection or other acute illnesses including fever on or the day prior to or day of receiving AZD7442.
- •History of SARS-CoV-1 or Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
- •Cohorts 1 and 2: Current need for immediate medical attention in an emergency room service or current need for hospitalization.
- •Mechanical ventilation or extracorporeal membrane oxygenation requirement for COVID-19.
- •History of allergic or reaction to any component of the study drug formulation.
- •History of hypersensitivity, injection/infusion-relation reactions or severe adverse reactions following administration of a mAb.
- •Co-morbidity requiring surgery within 7 days prior to study entry or is deemed life-threatening within 30 days prior to study entry.
- •THERAPY PRIOR ENROLLMENT
- •Prior receipt of convalescent COVID-19 plasma/sera or hyperimmune globulin therapy.
- •Prior receipt of mAb/biologic indicated for the prevention of SARS-CoV-2, treatment of COVID-19, or expected receipt during the period of study follow-up.
- •Prior receipt of a COVID-19 vaccine = 14 days before screening or plan to receive a COVID-19 vaccination = 14 days after IMP administration at study Visit 1.
- •History of alcohol or drug abuse within the past 2 years.
- •Vulnerable persons (ward of the state, kept in detention).
研究者
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